Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
This demonstrates our continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology.
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Roche's Elecsys sFlt-1/PlGF ratio for predicting preeclampsia risk receives FDA 510(k) clearance
Identifying patients at high risk of developing severe preeclampsia can lead to better prediction, earlier interventions and reduced adverse outcomes.
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
The first and only FDA-approved companion diagnostic for assessing HER2-low status since 2022 is now also approved to aid in the assessment of HER2-ultralow status for patients with MBC.
Roche announces U.S. investment in diagnostics and pharmaceuticals
Over five years, this will create jobs and expand R&D and manufacturing facilities across multiple states.
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A qPCR system designed to deliver accuracy and flexibility to research and clinical diagnostic laboratories.
A qPCR system designed to deliver accuracy and flexibility to research and clinical diagnostic laboratories.
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